Everolimus and Octreotide in Patients With Advanced Carci... | NCT00412061

ID	Type	Description	Link
2006-004507-18	EudraCT Number

Label	Type	Description	Intervention Names
Octreotide+ Everolimus	Experimental	Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.	Drug: Octreotide Drug: Everolimus
Octreotide+ Placebo	Placebo Comparator	Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.	Drug: Octreotide Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Octreotide	Drug	Octreotide 30 mg intramuscularly (i.m.) every 28 days.	Octreotide+ Everolimus Octreotide+ Placebo

Measure	Description	Time Frame
Progression Free Survival (PFS) as Per Adjudicated Central Radiology Review	Progression free survival (PFS) is defined as the time from randomization to the date of first documented disease progression or death from any cause. The primary analysis of PFS was based on the independent central adjudicated assessment using Kaplan-Meier method.	Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010

Measure	Description	Time Frame
Best Overall Response Rate as Per Adjudicated Central Radiology Review Based on Response Evaluation Criteria in Solid Tumors (RECIST)	The best overall response rate is defined as the percentage of patients having achieved confirmed Complete Response + Partial Response. Complete Response (CR) = at least two determinations of CR at least 4 weeks apart before progression. • Partial response (PR) = at least two determinations of PR or better at least 4 weeks apart before progression.

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Arizona / Arizona Cancer Center Deptof Uof A/Arizona Cancer(2)		Tucson	Arizona	85719	United States

PubMed Identifier	Type	Citation	Retractions
28444114	Derived	Pavel ME, Baudin E, Oberg KE, Hainsworth JD, Voi M, Rouyrre N, Peeters M, Gross DJ, Yao JC. Efficacy of everolimus plus octreotide LAR in patients with advanced neuroendocrine tumor and carcinoid syndrome: final overall survival from the randomized, placebo-controlled phase 3 RADIANT-2 study. Ann Oncol. 2017 Jul 1;28(7):1569-1575. doi: 10.1093/annonc/mdx193.
23187897

Label	URL
Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.	View source

ID	Title	Description
FG000	Octreotide+ Everolimus	Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Progression Free Survival (PFS) as Per Adjudicated Central Radiology Review

Progression free survival (PFS) is defined as the time from randomization to the date of first documented disease progression or death from any cause. The primary analysis of PFS was based on the independent central adjudicated assessment using Kaplan-Meier method.

The Full Analysis Set (FAS) consisted of all randomized patients.

Posted

Median

95% Confidence Interval

Months

Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010

ID	Title	Description
OG000	Octreotide+ Everolimus	Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
OG001	Octreotide+ Placebo	Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.

Units	Counts
Participants	OG000216 OG001213

Title

Denominators

Categories

Title	Measurements
	OG00016.43(13.67 to 21.19) OG00111.33(8.44 to 14.59)

Secondary

Best Overall Response Rate as Per Adjudicated Central Radiology Review Based on Response Evaluation Criteria in Solid Tumors (RECIST)

The best overall response rate is defined as the percentage of patients having achieved confirmed Complete Response + Partial Response. Complete Response (CR) = at least two determinations of CR at least 4 weeks apart before progression. • Partial response (PR) = at least two determinations of PR or better at least 4 weeks apart before progression.

The Full Analysis Set (FAS; Intent-to-treat Population) consists of all randomized patients.

Posted

Number

95% Confidence Interval

Percentage of patients

ID	Title	Description
OG000	Octreotide+ Everolimus	Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
OG001	Octreotide+ Placebo	Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.

Secondary

Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline 5-hydroxyindoleacetic Acid (5-HIAA) Level

5-HIAA levels in urine are frequently elevated in patients with advanced carcinoid tumors. Baseline levels of 5-HIAA in urine were defined as 'High' if they exceeded the median value, and 'Low' if they were lower than or equal to the median.

The Full Analysis Set (FAS; Intent-to-treat Population) consists of all randomized patients. This analysis includes PFS patients with non missing baseline 5-HIAA data.

Posted

Median

95% Confidence Interval

Months

If elevated at baseline, evaluated every cycle visit (28 days/cycle) reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010

ID	Title	Description
OG000	Octreotide+ Everolimus	Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
OG001	Octreotide+ Placebo	Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.

Secondary

Overall Survival Using Kaplan-Meier Methodology

Overall survival was defined as the time from the date of randomization to the date of death from any cause. If a patient was not known to have died, survival was censored at the date of last contact. Kaplan-Meier methodology was used to estimate the median overall survival for each treatment group.

The Full Analysis Set (FAS; Intent-to-treat Population) consists of all randomized patients.

Posted

Number

95% Confidence Interval

Percentage of Participants

Months 12, 24, 36, 48

ID	Title	Description
OG000	Octreotide+ Everolimus	Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
OG001	Octreotide+ Placebo Followed by Open Label Arm	Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1. Open Label - Patients who had progressive disease in this arm, can move to the open label Everolimus + depot octreotide by choice.

Secondary

Number of Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) (Double-Blind Phase)

AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.

The Safety Set consists of all patients who received at least one dose of study drug and who had at least one valid post-baseline safety assessment.

Posted

Number

Patients

From first day of treatment up to 28 days after last day of treatment in double blind

ID	Title	Description
OG000	Octreotide+ Everolimus	Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
OG001	Octreotide+ Placebo

Secondary

Number of Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) (Open Label Phase)

The Safety Set consists of all patients who received at least one dose of study drug and who had at least one valid post-baseline safety assessment.

Posted

Number

Patients

From first day of treatment up to 28 days after last day of treatment in double blind

ID	Title	Description
OG000	Everolimus Open Label Arm	Patients who had progressive disease in this arm, can move to the open label Everolimus + depot octreotide by choice.

Units	Counts
Participants	OG000

Secondary

Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline Chromogranin A (CgA)

Serum CgA levels in urine are frequently elevated in patients with advanced carcinoid tumors. Baseline levels of serum CgA were characterized relative to the upper limited of normal (ULN). CgA levels exceeding 2 x ULN were considered to be 'Elevated'; otherwise considered as "Non-elevated".

The Full Analysis Set (FAS; Intent-to-treat Population) consists of all randomized patients. This analysis includes PFS patients with non missing baseline CgA data.

Posted

Median

95% Confidence Interval

Months

If elevated at baseline, evaluated every cycle visit (28 days/cycle) reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010

ID	Title	Description
OG000	Octreotide+ Everolimus	Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
OG001	Octreotide+ Placebo	Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0004 affected215 at risk EG0012 affected211 at risk EG0024 affected170 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0022 affected170 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0003 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Angina pectoris	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected215 at risk EG0013 affected211 at risk EG0021 affected170 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Arrhythmia	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Atrial fibrillation	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0021 affected170 at risk
Atrial flutter	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0021 affected170 at risk
Carcinoid heart disease	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected215 at risk EG0012 affected211 at risk EG0022 affected170 at risk
Cardiac arrest	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Cardiac failure	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected215 at risk EG0012 affected211 at risk EG0020 affected170 at risk
Cardiac valve disease	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Coronary artery disease	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Dilatation ventricular	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Mitral valve stenosis	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0012 affected211 at risk EG0021 affected170 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Palpitations	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Pericardial effusion	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Pulmonary valve incompetence	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Pulmonary valve stenosis	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Right ventricular failure	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Stress cardiomyopathy	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Tachycardia paroxysmal	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Tricuspid valve disease	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Tricuspid valve incompetence	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0012 affected211 at risk EG0020 affected170 at risk
Tricuspid valve prolapse	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Tricuspid valve stenosis	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Atrial septal defect	Congenital, familial and genetic disorders	MedDRA	Systematic Assessment	EG0002 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Vertigo	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Adrenocortical insufficiency acute	Endocrine disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Carcinoid crisis	Endocrine disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Carcinoid syndrome	Endocrine disorders	MedDRA	Systematic Assessment	EG0002 affected215 at risk EG0011 affected211 at risk EG0022 affected170 at risk
Diplopia	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Abdominal adhesions	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0011 affected211 at risk EG0021 affected170 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00015 affected215 at risk EG00111 affected211 at risk EG00211 affected170 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0012 affected211 at risk EG0021 affected170 at risk
Ascites	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0015 affected211 at risk EG0020 affected170 at risk
Colitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Constipation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0009 affected215 at risk EG0015 affected211 at risk EG0027 affected170 at risk
Duodenal obstruction	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Duodenal stenosis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0022 affected170 at risk
Enteritis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Faeces discoloured	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Food poisoning	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0012 affected211 at risk EG0020 affected170 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0021 affected170 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Gastrointestinal angiodysplasia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Gastrointestinal fistula	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0011 affected211 at risk EG0022 affected170 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Haematemesis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Haematochezia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Ileus	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0005 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Inguinal hernia, obstructive	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Intestinal angina	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected215 at risk EG0015 affected211 at risk EG0023 affected170 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0022 affected170 at risk
Lip oedema	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Melaena	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0021 affected170 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0004 affected215 at risk EG0014 affected211 at risk EG0022 affected170 at risk
Oesophageal spasm	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Pneumatosis intestinalis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Small intestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0008 affected215 at risk EG0013 affected211 at risk EG0024 affected170 at risk
Small intestinal stenosis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Stomatitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Subileus	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 affected215 at risk EG0012 affected211 at risk EG0020 affected170 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0007 affected215 at risk EG0016 affected211 at risk EG0025 affected170 at risk
Asthenia	General disorders	MedDRA	Systematic Assessment	EG0002 affected215 at risk EG0013 affected211 at risk EG0021 affected170 at risk
Brain death	General disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Chest pain	General disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0011 affected211 at risk EG0021 affected170 at risk
Chills	General disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Face oedema	General disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Fatigue	General disorders	MedDRA	Systematic Assessment	EG0002 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
General physical health deterioration	General disorders	MedDRA	Systematic Assessment	EG0006 affected215 at risk EG0013 affected211 at risk EG0025 affected170 at risk
Generalised oedema	General disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Hypothermia	General disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Malaise	General disorders	MedDRA	Systematic Assessment	EG0002 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Non-cardiac chest pain	General disorders	MedDRA	Systematic Assessment	EG0003 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Oedema peripheral	General disorders	MedDRA	Systematic Assessment	EG0003 affected215 at risk EG0014 affected211 at risk EG0023 affected170 at risk
Pain	General disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0012 affected211 at risk EG0020 affected170 at risk
Performance status decreased	General disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG0008 affected215 at risk EG0013 affected211 at risk EG0023 affected170 at risk
Spinal pain	General disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Sudden death	General disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Bile duct obstruction	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Cholangitis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Cholangitis acute	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0002 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Cholestasis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0002 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Hepatocellular injury	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Jaundice	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Drug hypersensitivity	Immune system disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Abdominal wall abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0021 affected170 at risk
Abscess intestinal	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Arthritis infective	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Aspergillosis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Bacteraemia	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Bronchiolitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Bronchopneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Cellulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0003 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Cholecystitis infective	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Diverticulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Erysipelas	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Escherichia sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Gastroenteritis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected215 at risk EG0011 affected211 at risk EG0022 affected170 at risk
Gastroenteritis viral	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0021 affected170 at risk
Herpes zoster	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Infected skin ulcer	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Influenza	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Localised infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0022 affected170 at risk
Lung infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0022 affected170 at risk
Osteomyelitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Peritonitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0009 affected215 at risk EG0011 affected211 at risk EG0025 affected170 at risk
Pneumonia viral	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected215 at risk EG0011 affected211 at risk EG0024 affected170 at risk
Sinusitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Staphylococcal infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected215 at risk EG0012 affected211 at risk EG0020 affected170 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0012 affected211 at risk EG0020 affected170 at risk
Urosepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Bone fissure	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Fractured sacrum	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Heat exhaustion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Pulmonary contusion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Scapula fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Traumatic intracranial haemorrhage	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Alanine aminotransferase increased	Investigations	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Aspartate aminotransferase increased	Investigations	MedDRA	Systematic Assessment	EG0002 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Blood creatinine increased	Investigations	MedDRA	Systematic Assessment	EG0002 affected215 at risk EG0010 affected211 at risk EG0024 affected170 at risk
Blood urea increased	Investigations	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Cardiac murmur	Investigations	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Coagulation time shortened	Investigations	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Heart rate increased	Investigations	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Lipase increased	Investigations	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Weight decreased	Investigations	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0002 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0022 affected170 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0007 affected215 at risk EG0011 affected211 at risk EG0023 affected170 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0021 affected170 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0002 affected215 at risk EG0010 affected211 at risk EG0023 affected170 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0002 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0002 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0004 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0002 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0012 affected211 at risk EG0020 affected170 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0002 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0014 affected211 at risk EG0021 affected170 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0021 affected170 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
B-cell type acute leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Brain neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Lung infiltration malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Metastatic pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Tumour compression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0021 affected170 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Convulsion	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Dizziness postural	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Encephalopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Facial paresis	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Grand mal convulsion	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0012 affected211 at risk EG0020 affected170 at risk
Hypoaesthesia	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Intracranial haematoma	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Lethargy	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Mental impairment	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Radicular syndrome	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Radiculopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Sciatica	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Syncope	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 affected215 at risk EG0011 affected211 at risk EG0022 affected170 at risk
Confusional state	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0011 affected211 at risk EG0021 affected170 at risk
Depression	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Hallucination	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Mental status changes	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Bladder tamponade	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Calculus urinary	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Eosinophilic cystitis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Haematuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0021 affected170 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0011 affected211 at risk EG0022 affected170 at risk
Renal failure	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0004 affected215 at risk EG0010 affected211 at risk EG0023 affected170 at risk
Renal failure acute	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0003 affected215 at risk EG0011 affected211 at risk EG0021 affected170 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Renal impairment	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Renal infarct	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Ureteric obstruction	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Urinary bladder haemorrhage	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Urinary retention	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Testicular swelling	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0008 affected215 at risk EG0012 affected211 at risk EG0021 affected170 at risk
Granulomatous pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0003 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0003 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Laryngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Organising pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0003 affected215 at risk EG0010 affected211 at risk EG0022 affected170 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 affected215 at risk EG0010 affected211 at risk EG0022 affected170 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0006 affected215 at risk EG0011 affected211 at risk EG0023 affected170 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0021 affected170 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Aortic dissection	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Deep vein thrombosis	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0011 affected211 at risk EG0022 affected170 at risk
Flushing	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Haematoma	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0011 affected211 at risk EG0021 affected170 at risk
Hypotension	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected215 at risk EG0011 affected211 at risk EG0020 affected170 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Orthostatic hypotension	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk
Phlebitis	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected215 at risk EG0010 affected211 at risk EG0020 affected170 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG00058 affected215 at risk EG00121 affected211 at risk EG00234 affected170 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG00016 affected215 at risk EG0012 affected211 at risk EG0022 affected170 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG00018 affected215 at risk EG0013 affected211 at risk EG00213 affected170 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG00034 affected215 at risk EG0011 affected211 at risk EG00215 affected170 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00012 affected215 at risk EG00112 affected211 at risk EG00210 affected170 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00065 affected215 at risk EG00168 affected211 at risk EG00243 affected170 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00022 affected215 at risk EG00126 affected211 at risk EG00216 affected170 at risk
Aphthous stomatitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00028 affected215 at risk EG0013 affected211 at risk EG00215 affected170 at risk
Ascites	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00017 affected215 at risk EG0019 affected211 at risk EG0028 affected170 at risk
Constipation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00031 affected215 at risk EG00122 affected211 at risk EG00217 affected170 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG000114 affected215 at risk EG00177 affected211 at risk EG00277 affected170 at risk
Dry mouth	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00022 affected215 at risk EG0016 affected211 at risk EG0027 affected170 at risk
Dysphagia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00015 affected215 at risk EG0015 affected211 at risk EG0024 affected170 at risk
Flatulence	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00027 affected215 at risk EG00128 affected211 at risk EG00212 affected170 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00017 affected215 at risk EG0019 affected211 at risk EG0029 affected170 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00017 affected215 at risk EG0015 affected211 at risk EG00211 affected170 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00092 affected215 at risk EG00163 affected211 at risk EG00260 affected170 at risk
Stomatitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG000109 affected215 at risk EG00125 affected211 at risk EG00263 affected170 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00069 affected215 at risk EG00140 affected211 at risk EG00230 affected170 at risk
Asthenia	General disorders	MedDRA	Systematic Assessment	EG00051 affected215 at risk EG00130 affected211 at risk EG00230 affected170 at risk
Chills	General disorders	MedDRA	Systematic Assessment	EG00015 affected215 at risk EG00110 affected211 at risk EG0025 affected170 at risk
Fatigue	General disorders	MedDRA	Systematic Assessment	EG000103 affected215 at risk EG00191 affected211 at risk EG00263 affected170 at risk
Oedema peripheral	General disorders	MedDRA	Systematic Assessment	EG00092 affected215 at risk EG00147 affected211 at risk EG00262 affected170 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG00042 affected215 at risk EG00121 affected211 at risk EG00232 affected170 at risk
Bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG00011 affected215 at risk EG0017 affected211 at risk EG0028 affected170 at risk
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG00019 affected215 at risk EG00126 affected211 at risk EG00219 affected170 at risk
Sinusitis	Infections and infestations	MedDRA	Systematic Assessment	EG00012 affected215 at risk EG0019 affected211 at risk EG00217 affected170 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG00027 affected215 at risk EG00112 affected211 at risk EG00211 affected170 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG00027 affected215 at risk EG00116 affected211 at risk EG00219 affected170 at risk
Alanine aminotransferase increased	Investigations	MedDRA	Systematic Assessment	EG0009 affected215 at risk EG0016 affected211 at risk EG00210 affected170 at risk
Aspartate aminotransferase increased	Investigations	MedDRA	Systematic Assessment	EG00011 affected215 at risk EG0018 affected211 at risk EG0028 affected170 at risk
Blood creatinine increased	Investigations	MedDRA	Systematic Assessment	EG00015 affected215 at risk EG0015 affected211 at risk EG0028 affected170 at risk
Weight decreased	Investigations	MedDRA	Systematic Assessment	EG00059 affected215 at risk EG00131 affected211 at risk EG00233 affected170 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00064 affected215 at risk EG00136 affected211 at risk EG00233 affected170 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00017 affected215 at risk EG00112 affected211 at risk EG0029 affected170 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00017 affected215 at risk EG0016 affected211 at risk EG0027 affected170 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00042 affected215 at risk EG0019 affected211 at risk EG00224 affected170 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00015 affected215 at risk EG0013 affected211 at risk EG0024 affected170 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00017 affected215 at risk EG0014 affected211 at risk EG00211 affected170 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00050 affected215 at risk EG0018 affected211 at risk EG00227 affected170 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00015 affected215 at risk EG0015 affected211 at risk EG0026 affected170 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00011 affected215 at risk EG0016 affected211 at risk EG0028 affected170 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00038 affected215 at risk EG00128 affected211 at risk EG00219 affected170 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00033 affected215 at risk EG00141 affected211 at risk EG00218 affected170 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00017 affected215 at risk EG00113 affected211 at risk EG00210 affected170 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00018 affected215 at risk EG0017 affected211 at risk EG00211 affected170 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00021 affected215 at risk EG00121 affected211 at risk EG0028 affected170 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00016 affected215 at risk EG00114 affected211 at risk EG0028 affected170 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00032 affected215 at risk EG00124 affected211 at risk EG00219 affected170 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG00029 affected215 at risk EG00124 affected211 at risk EG00212 affected170 at risk
Dysgeusia	Nervous system disorders	MedDRA	Systematic Assessment	EG00042 affected215 at risk EG00112 affected211 at risk EG00230 affected170 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG00065 affected215 at risk EG00149 affected211 at risk EG00232 affected170 at risk
Anxiety	Psychiatric disorders	MedDRA	Systematic Assessment	EG00014 affected215 at risk EG00114 affected211 at risk EG00212 affected170 at risk
Depression	Psychiatric disorders	MedDRA	Systematic Assessment	EG00016 affected215 at risk EG00111 affected211 at risk EG00212 affected170 at risk
Insomnia	Psychiatric disorders	MedDRA	Systematic Assessment	EG00020 affected215 at risk EG00115 affected211 at risk EG00212 affected170 at risk
Dysuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG00012 affected215 at risk EG0015 affected211 at risk EG0027 affected170 at risk
Pollakiuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG00010 affected215 at risk EG0016 affected211 at risk EG00211 affected170 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00059 affected215 at risk EG00132 affected211 at risk EG00238 affected170 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00059 affected215 at risk EG00119 affected211 at risk EG00227 affected170 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0009 affected215 at risk EG00111 affected211 at risk EG0027 affected170 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00033 affected215 at risk EG0015 affected211 at risk EG00224 affected170 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00020 affected215 at risk EG0016 affected211 at risk EG00213 affected170 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00012 affected215 at risk EG0016 affected211 at risk EG0027 affected170 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00020 affected215 at risk EG0012 affected211 at risk EG0026 affected170 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG00013 affected215 at risk EG0014 affected211 at risk EG0027 affected170 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG00023 affected215 at risk EG0015 affected211 at risk EG0029 affected170 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG00017 affected215 at risk EG0014 affected211 at risk EG0027 affected170 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0009 affected215 at risk EG00113 affected211 at risk EG0025 affected170 at risk
Onychoclasis	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG00011 affected215 at risk EG0011 affected211 at risk EG00210 affected170 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG00042 affected215 at risk EG00112 affected211 at risk EG00218 affected170 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG00088 affected215 at risk EG00137 affected211 at risk EG00259 affected170 at risk
Flushing	Vascular disorders	MedDRA	Systematic Assessment	EG00020 affected215 at risk EG00120 affected211 at risk EG0026 affected170 at risk
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG00024 affected215 at risk EG00121 affected211 at risk EG00216 affected170 at risk

ID	Term
D002276	Carcinoid Tumor
D008303	Malignant Carcinoid Syndrome
D009369	Neoplasms
D002277	Carcinoma

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type
D000230	Adenocarcinoma
D009375	Neoplasms, Glandular and Epithelial
D009380	Neoplasms, Nerve Tissue

ID	Term
D010456	Peptides, Cyclic
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D020123	Sirolimus
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals

ID	Title	Description
BG000	Octreotide+ Everolimus	Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
BG001	Octreotide+ Placebo	Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.
BG002	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Everolimus + Octreotide	Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.	126	215	214	215
EG001	Placebo + Octreotide	Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.	74	211	194	211
EG002	Everolimus Open Label	Open Label - Patients who had progressive disease in this arm, can move to the open label Everolimus + depot octreotide by choice.	93	170	162	170